CMC Regulatory Affairs Specialist
3 weeks ago
The CMC Regulatory Affairs Specialist is responsible for for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.
E ssential Duties and Responsibilities include, but are not limited to, the following:
* Plans and conducts critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval.
* Reviews Change Controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary.
* Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.
* Provides CMC-related mentorship to IOPS so that their short-term and long-term goals are achieved on time and with highest quality.
* Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests.
E ducation and Experience:
• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred).
• 2+ years of experience working in the biopharmaceutical manufacturing or related industry including experience in regulatory or compliance related activities.
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Inc. Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Solicitar locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Tiempo completo posted on Publicado hoy job requisition id R5643497 McDermott Laboratories Limited En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris inc. Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Apply locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Full time posted on Posted Today job requisition id R5643497 McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Postuler locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Temps plein posted on Offre publiée aujourd'hui job requisition id R5643497 McDermott Laboratories Limited Chez Viatris, nous envisageons la santé non pas telle qu'elle est...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Regulatory Manager
1 month ago
Dublin, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...
-
Regulatory Affairs Specialist
4 weeks ago
Dublin, Ireland Glanbia Full timeThe Opportunity The Regulatory Affairs Specialist is responsible for supporting product commercialization, for GPN owned and contract brands, for all activities involving regulatory compliance from concept to launch. This role will play a critical role in delivery of the growth objectives of the EMEA region. Ensuring Product Compliance to local...
-
Regulatory Affairs Officer
1 month ago
Dublin, Ireland Viatris Inc. Full timeRegulatory Affairs Officer page is loaded Regulatory Affairs Officer Solicitar locations Northern Cross, Dublin, Ireland time type Tiempo completo posted on Publicado hoy job requisition id R5644288 McDermott Laboratories Limited En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición...
-
Regulatory Affairs Officer
1 month ago
Dublin, Ireland Viatris Full timeRegulatory Affairs Officer page is loaded Regulatory Affairs Officer Postuler locations Northern Cross, Dublin, Ireland time type Temps plein posted on Offre publiée aujourd'hui job requisition id R5644288 McDermott Laboratories Limited Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons...
-
Senior Regulatory Affairs Associate
4 weeks ago
Dublin, Ireland Perrigo Full timeDescription Overview In this role you will be handling licensing and post marketing activities for the centrally managed medicinal products mainly in the Nicotine Replacement Therapy (NRT) and Gastrointestinal (GI) categories in Perrigo’s International business division (mainly EU) (CSCI) Exposure within EU regulatory framework Lead regulatory...
-
Director - Global Regulatory Strategy
1 month ago
Dublin, Ireland Mallinckrodt Pharmaceuticals Full timeDescription Summary Serves as a key regulatory interface with Global Health Authorities and acts as global regulatory lead for product brand teams to develop, maintain and obtain alignment of global regulatory strategies in accordance with business plans. The incumbent is expected to exhibit leadership behaviors consistent with level and to act with...
-
Regulatory Affairs Officer
1 month ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Product Safety and Regulatory Affairs Specialist
3 weeks ago
Dublin, Ireland Henkel AG & Co. KGaA Full timeAt Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging the status quo, join our community of over 50,000 pioneers around the globe. Our teams at Henkel Adhesive Technologies help to transform entire industries and provide our customers with...
-
Product Safety and Regulatory Affairs Specialist
3 weeks ago
Dublin, Ireland Henkel Full timeAt Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging the status quo, join our community of over 50,000 pioneers around the globe. Our teams at Henkel Adhesive Technologies help to transform entire industries and provide our customers...
-
QA Specialist
2 weeks ago
Dublin, Ireland AstraZeneca GmbH Full timeThis is what you will do: The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones...
-
QA Specialist
2 weeks ago
Dublin, Ireland Alexion Pharmaceuticals Full timeThis is what you will do: The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones...
-
Global Director of Regulatory AffairsNew
1 week ago
Dublin, Ireland Next Generation Full timeExciting Opportunity: Global Director of Regulatory Affairs Company Overview: Our client, an expanding global biopharmaceutical company, is at the forefront of innovation in oncology therapeutics. With a commitment to improving patient outcomes, they are expanding their therapeutic portfolio and seeking a talented Global Director of Regulatory Affairs...
-
Regulatory Affairs Manager
1 month ago
Dublin, Ireland IQVIA Full timeThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Medical Affairs Scientist
18 hours ago
Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with our client Pfizer are seeking a Medical Affairs Scientist to join the team for an 12 month fixed term contract in their Dublin, Ringsend site. This role has a hybrid working model attached. Role Description •The Medical Affairs Scientist will be responsible to provide in country medical affairs support that is aligned and...
-
Medical Affairs Scientist
1 day ago
Dublin, Dublin City, Ireland Cpl Full timeCpl in partnership with our client Pfizer are seeking a Medical Affairs Scientist to join the team for an 12 month fixed term contract in their Dublin, Ringsend site. This role has a hybrid working model attached.Role DescriptionThe Medical Affairs Scientist will be responsible to provide in country medical affairs support that is aligned and integrated to...
-
Manager, Global Regulatory Requirements
4 weeks ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...